Every licensee shall maintain inventories, logs, and records prescribed in this rule.
Controlled substances dispensation/administration records must also meet all applicable federal statutes and regulations.
Patient Record - A licensee who prescribes, dispenses or administers a legend drug or controlled substance must maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any legend drug or controlled substance; the name, dose, strength, quantity of the legend drug or controlled substance and the date that the legend drug or controlled substance was prescribed, dispensed or administered. The record required by this rule must be maintained in the patient's medical records. If medical records are maintained at the office of the licensee, the records must be available for inspection by the representatives of the Mississippi State Board of Medical Licensure.
Licensees must not prescribe, administer or dispense any legend drug; any controlled substance; or any drug having addiction-forming or addiction-sustaining liability without a good faith prior examination and medical indication. A determination as to whether a "good faith prior examination and medical indication" exists depends upon the facts and circumstances in each case. One of the primary roles of a physician is to elicit detailed information about the signs and symptoms which a patient presents in order that he or she may recommend a course of treatment to relieve the symptoms and cure the patient of his or her ailment or maintain him or her in an apparent state of good health. In order for a licensee to achieve a reasonable diagnosis and treatment plan, a history and physical examination consistent with the nature of the complaint are necessary. The importance of these aspects of proper medical practice cannot be over emphasized. The paramount importance of a complete medical history in establishing a correct diagnosis is well established. Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a licensee must take three steps:
Some of the factors used in determining the presence or absence of "good faith" may include, but are not limited to:
The aforementioned is of particular importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the licensee to dispense, prescribe or administer all therapies with proper regard for the actual and potential dangers. This fact has been established in a number of closely related administrative and criminal cases, United States v. Bartee, 479 F.2d 484 (10th Cir. 1973) (No physical examination prior to issuance of prescriptions for controlled substances); United States v. Greene, 511 F.2d 1062 (7th Cir. 1975); Arthurs v. Board of Registration of Medicine, 418 N.E. 2d 1236 (MA 1981) (failure to record in patient file prescriptions for controlled substances issued or failure to record patient visit); Brainard v. State Board of Medical Examiners, 157 P2d 7 (Ca. 1945); Dannerberg v. Board of Regents, 430 N.Y.2d 700 (1980) (issuance of three prescriptions for sleeping pills to an undercover agent without a physical examination; Widlitz v. Board of Regents of New York, 429 N.Y. 2d 794 (1980) (issuance of Desoxyn to patients whom physician knew were drug addicts without conducting physical examination); United States v. Rosenberg, 515 F.2d 190 (9th Cir. 1975) (no physical examination, evidences that prescriptions were not in course of professional practice); and United States v. Hooker, 541 F.2d 300 (1st Cir. 1976), (little more than cursory physical examination, frequent neglect to inquire as to past medical history, little or no exploration of the type of problem the patient allegedly had "indicates that the minimal professional procedures followed were designed only to give an appearance of propriety to appellant's unlawful distributions").
A determination of proper "medical indication" requires examination of the nature of the therapy and all circumstances surrounding its implementation. Use of any therapy should be supported by standards of medical practice, reasonable scientific evidence or consensus and documented in the medical record. Case law developed by the courts in connection with controlled substances criminal violations and administrative decisions further illustrates several indications of lack of good faith. See United States v. Greene, 511 F.2d 1062 (7th Cir. 1975) and United States v. Rosenburg, 515 F.2d 190 (9th Cir. 1975). One of primary importance is the failure to follow at least the minimal professional procedures. Some of the factors used in determining the existence of "good faith" may include, but are not limited to:
A licensee must not sell or trade any medication which he or she receives as prepackaged samples or starter packs, whether or not said samples are controlled substances, legend drugs or other medication.
The Controlled Substances Inventory, Controlled Substance Dispensation/Administration Record, and Patient Record required by these rules must be maintained in the office of the licensee for a period of seven (7) years from the date that the record is completed or the controlled substances, legend drugs or other medications are prescribed, administered or dispensed and must be made available for inspection by representatives of the Mississippi State Board of Medical Licensure pursuant to authority granted in Mississippi Code, Section 41-29-125. Record retention for Controlled Substances Inventory, Controlled Substance Dispensation/Administration Record, and Patient Record must also meet all applicable federal statutes and regulations.
A licensee may use a data processing system or a manual record keeping system for the storage and retrieval of Controlled Substances Dispensation/Administration Records. If a licensee utilizes a data processing system, it must provide immediate retrieval of all dispensation/administration records of controlled substances.
Whether maintained manually or in a data processing system, all records of dispensation/administration of controlled substances must be readily retrievable. If a data processing system is utilized, a hard-copy printout of the records of dispensation/administration must be made at regular intervals, not to exceed seven (7) days. Such hard-copy printouts must be maintained for a period of five (5) years and must be made available for inspection and copying by investigators of the Mississippi State Board of Medical Licensure.
30 Miss. Code. R. 2640-1.4